Souza Beatriz Martines, Santos Daiana Moreli Soares, Braga Aline Silva, Santos Natália Mello Dos, Rios Daniela, Buzalaf Marilia Afonso Rabelo, Magalhães Ana Carolina
Department of Biological Sciences, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.
Department of Pediatric Dentistry, Orthodontic and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.
JMIR Res Protoc. 2018 Jan 26;7(1):e26. doi: 10.2196/resprot.9376.
Titanium tetrafluoride (TiF) has regained interest due to new formulations that have been shown to be more effective against tooth demineralization than sodium fluoride (NaF) formulations in vitro and in situ.
The aim of this study is to evaluate the effect of two types of varnishes (4% TiF and a commercial 5% NaF) on the prevention of carious lesions and the treatment of noncavitated enamel carious lesions in the permanent teeth of children living in a fluoridated area.
This randomized, controlled, parallel and single-blind clinical trial involves 63 children, 6-7 years old, living in Bauru, São Paulo, Brazil. Children were selected according to their caries activity (ie, presence of at least 1 tooth with a Nyvad score of 1) and randomly divided into the following treatment categories: 4% TiF varnish (2.45 % F, pH 1, FGM); 5% NaF varnish (2.26% F, pH 5, Duraphat, Colgate) and control (placebo varnish, pH 5, FGM). The varnishes will be applied on all permanent teeth, once a week for 4 weeks and they will be reapplied only once 6 and 12 months after the study begins. Two calibrated examiners will carry out the clinical examination (International Caries Detection and Assessment System [ICDAS] and Nyvad indexes, kappa>.8) at baseline, before the first application, after the 1st, 6th, 12th, and 18th month of the study begins. Furthermore, quantitative fluorescence changes will be measured using Quantitative Light-Induced Fluorescence (QLF). The degree of patient satisfaction with the treatment will also be computed. The data will undergo statistical analysis (P<.05).
This ongoing study is funded by funding agencies from Brazil (São Paulo Research Foundation, FAPESP-015/14149-1, and National Council for Scientific and Technological Development, CNPq-401313/2016-6). We expect to confirm the efficacy of TiF on the prevention and treatment of carious lesions by comparing it to NaF varnish. The subjects are under 1 month evaluation and the dropout was about 8%. No differences between the treatments have been detected at the first month so far (P>.05).
If our hypothesis is confirmed, TiF varnish can be marketed and applied at the individual level and used in community programs to control dental caries.
Brazilian Clinical Trials Registry: RBR-5VWJ4Y; http://www.ensaiosclinicos.gov.br/rg/?q=RBR-5VWJ4Y (Archived by WebCite at http://www.webcitation.org/6wUurEnm7).
四氟化钛（TiF）因新配方而重新受到关注，这些新配方在体外和原位研究中已显示出比氟化钠（NaF）配方更有效地防止牙齿脱矿。
本研究旨在评估两种类型的清漆（4% TiF和市售5% NaF）对生活在氟化地区儿童恒牙龋损预防和非龋洞性釉质龋损治疗的效果。
这项随机、对照、平行和单盲临床试验涉及63名6 - 7岁生活在巴西圣保罗包鲁市的儿童。根据他们的龋病活动情况（即至少有1颗牙齿的Nyvad评分为1）选择儿童，并随机分为以下治疗组：4% TiF清漆（2.45% F，pH 1，FGM）；5% NaF清漆（2.26% F，pH 5，Duraphat，高露洁）和对照组（安慰剂清漆，pH 5，FGM）。清漆将应用于所有恒牙，每周一次，共4周，并且仅在研究开始后的6个月和12个月重新涂抹一次。两名经过校准的检查人员将在基线、首次涂抹前、研究开始后的第1、6、12和18个月进行临床检查（国际龋病检测与评估系统[ICDAS]和Nyvad指数，kappa>.8）。此外，将使用定量光诱导荧光（QLF）测量定量荧光变化。还将计算患者对治疗的满意度。数据将进行统计分析（P<.05）。
这项正在进行的研究由巴西的资助机构资助（圣保罗研究基金会，FAPESP - 015/14149 - 1，以及国家科学技术发展委员会，CNPq - 401313/2016 - 6）。我们期望通过将TiF与NaF清漆进行比较来证实TiF对龋损预防和治疗的疗效。受试者处于1个月的评估期内，失访率约为8%。到目前为止，在第一个月尚未检测到治疗组之间的差异（P>.05）。
如果我们的假设得到证实，TiF清漆可以进行市场推广并应用于个体层面，也可用于社区项目以控制龋齿。
巴西临床试验注册中心：RBR - 5VWJ4Y；http://www.ensaiosclinicos.gov.br/rg/?q = RBR - 5VWJ4Y（由WebCite存档于http://www.webcitation.org/6wUurEnm7）
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